INTEGRA INTERSPINOUS PROCESS SYSTEM

Spinous Process Plate

SEASPINE, INC.

The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Integra Interspinous Process System.

Pre-market Notification Details

Device IDK121924
510k NumberK121924
Device Name:INTEGRA INTERSPINOUS PROCESS SYSTEM
ClassificationSpinous Process Plate
Applicant SEASPINE, INC. 2302 La Mirada Dr Vista,  CA  92081
ContactNick M Cordaro
CorrespondentNick M Cordaro
SEASPINE, INC. 2302 La Mirada Dr Vista,  CA  92081
Product CodePEK  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-02
Decision Date2013-09-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10889981129705 K121924 000
10889981076191 K121924 000
10889981076207 K121924 000
10889981076214 K121924 000
10889981076221 K121924 000
10889981076238 K121924 000
10889981096199 K121924 000
10889981096236 K121924 000
10889981096243 K121924 000
10889981096250 K121924 000
10889981096267 K121924 000
10889981096274 K121924 000
10889981096281 K121924 000
10889981120603 K121924 000
10889981076184 K121924 000

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